Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVanderbilt University Medical Center
About this trial
The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking.
In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated.
Participants will be randomized to one of three study groups:
1. Depression cognitive training treatment with active brain stimulation 2. Depression cognitive training treatment with sham brain stimulation 3. Non-specific cognitive training treatment with sham brain stimulation
The main questions this clinical trial aims to answer are:
* Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments? * Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments?
Participants will:
* Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months. * Visit the research center daily for 4 weeks to complete their assigned treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 60 years
Evidence of executive dysfunction via SUBJECTIVE COMPLAINTS (At least one subdomain of the Behavior Rating Inventory of Executive Function in Adults (BRIEF-A) at T > 65, or At least one average score of > 1.5 on Planning, Organization, or Attention subdomains of the Everyday Cognition Scale (ECog)) or OBJECTIVE PERFORMANCE (At least one demographically adjusted z-score > -1.0 SD below the mean on a measure of executive functioning (Digits backward, Trails B, or total Verbal Fluency) on the National Alzheimer's Coordinating Center (NACC) Uniform Data Set 3.0).
DSM-5 diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) via the using the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
Presence of 2 or more lifetime depressive episodes to be considered "recurrent."
Disqualifiers
Other psychiatric conditions via the SCID-5 (including history of bipolar disorder and psychosis, excluding comorbid anxiety disorders)
Severe depression (MADRS score > 29)
Acute suicidality on clinical evaluation by study clinician and via response on MADRS item 10 (score of 4 or more would require further assessment)
Acute grief (occurring within past month)
Trial design
Design model
Parallel
Treatments tested in this trial
Depression Cognitive Training
BehavioralComputerized cognitive training targeting the underlying cerebral networks associated with depression.
Non-Specific Cognitive Training
BehavioralComputerized cognitive training that provides extra stimulation for the brain that is non-specific.
tDCS (active stimulation)
DeviceA Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0 milliamps (mA) direct current through two bicarbon rubber electrodes encased in saline soaked 5 cm x 7 cm sponges (8 cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (via 10-20 system).
tDCS (sham stimulation)
DeviceSham stimulation will be performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Depression Cognitive Training + Active StimulationExperimental treatment 2 interventions
Group B: Depression Cognitive Training + Sham StimulationExperimental treatment 2 interventions
Group C: Non-Specific Cognitive Training + Sham StimulationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
NIH Examiner
This objective cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, and planning). The investigators will examine intervention-related change its Executive Composite Score (primary outcome), and subcomposite (Cognitive Control, Working Memory, and Fluency; secondary outcomes) scores, where higher scores indicate better performance.
Time frame
Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention2
Resting state fMRI functional connectivity
Functional connectivity from resting state fMRI will be processed using the CONN toolbox for connectivity, incorporating the Shaeffer network atlases to improve peer-research supported network usage in addition to the standard CONN atlases. A priori ROI-to-ROI analyses will be used to determine whether average connectivity changes in the Executive Control Network differs by treatment group. Analyses will control for multiple comparisons at false discovery rate (FDR) \< 0.05.
Time frame
Baseline, Following completion of the 4-week interventionSecondary outcomes
1
Montgomery Asberg Depression Rating Scale
The MADRS is a 10-item clinician-rated measure of depression severity, with higher scores indicating greater symptom severity. We will look at change in depression severity over the course of the intervention by treatment arm in Exploratory Analyses.
Time frame
Baseline and weekly thereafter, Following completion of the 4-week intervention, 3-Month Post-InterventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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